Kornimate/medical-research-clean huggingface dataset:
influence of intragastric fatty acid infusion on behavioral responses to positive emotion induction in healthy subjects

Conditions: Healthy Volunteers

Summary: the purpose of this study is to test whether intragastrically infused fatty acid will interact with positive emotion induction and if this effect is mediated by gut hormones.

this study aims at the possible effect of subliminal intragastric administration of fatty acids on responses to positive emotion induction, based on our earlier findings that subjective administration of fatty acid decreases neural responses to negative mood induction (van oudenhove et al, j clin invest 2011). after screening for exclusion criteria and the participants sign the informed consent form, an intravenous catheter is placed in the forearm, and a naso-gastric tube inserted through the nose. then the test subject is connected to the equipment in order to record the activity of the autonomic nervous system, via three electrocardiogram electrodes. by using the nasogastric tube we serve a fatty acid solution (dodecanoic acid, "fatty acid" condition) or a physiological saline solution ( "control" condition) intragastrically. the intragastric administration of low doses of this food ingredient has already been used in several previous studies by our research group and has proven perfectly safe. a positive or neutral emotional state will be induced by the combination of looking at emotional facial expressions and listening to classical music pieces that were previously validated for this purpose; this combination of incentives has already been used in previous studies of our research group. responses will be measured by means of validated self-report scales and measurements of the vagal tone. we also take blood samples on a regular basis by the intravenous catheter for determination of gastrointestinal hormones, given our hypothesis that this may explain the effect on emotions. after removal of the nasogastric tube, the influence of subliminal administration of fatty acids and emotional state on food intake measured by means of a validated and previously drink test used in which participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means of classical music pieces continue. finally, the intravenous catheter is removed.

Eligibility criteria:
inclusion criteria: * healthy women * age \> 18 and \< 60. * body mass index (bmi) of 19-25 kg/m2 (no weight change of more than 5% of body weight in the past three months). exclusion criteria: * chronic medical illness affecting the gastrointestinal, endocrine, cardiovascular or nervous system (risk of) pregnancy history of upper gastrointestinal surgery history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain psychiatric disorders, including (history of) depression or eating disorders alcohol abuse or dependence regular use of medication, except for oral contraception use of any drugs, including cannabis, during the past 6 months
visper: randomised comparison of two ovds in cataract surgery

Conditions: Cataract Senile

Summary: to investigate that visthesia 1.5 is non-inferior to provisc with regards to elevation in iop greater than or equal to 30 mm hg 6 ± 2 hours post-operatively as per methodology set out in en iso 15798:2013 (primary endpoint) to compare the changes in endothelial cell count and incidences of intraocular inflammation between visthesia and provisc as per methodology set out in en iso 15798:2013


Eligibility criteria:
inclusion criteria: 1. patients of any gender, 50 years of age or older at the time of study enrolment 2. undergoing age-related cataract removal (phacoemulsification) and iol implantation in one eye only 3. patient informed of the needs and visit schedule required of the clinical investigational plan and who has given his/her written informed consent 4. planned implantation of the iol in the capsular bag exclusion criteria: 1. patients not able to / willing to give informed consent 2. patients not able to comprehend and comply with study requirements 3. patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (surgery date could be changed) 4. patients not able to attend follow-up appointments for any reason 5. patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan 6. patients with reduced corneal endothelium (e.g. fuch's dystrophy) 7. patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function 8. patients being treated with tocainide for cardiac arrhythmia 9. patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels 10. mono-ophthalmic patients 11. patients who have previously undergone cataract surgery in the contralateral eye 12. patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain 13. visthesia (topical and intracameral components) or provisc is not a suitable device for the patient for any reason 14. patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log) 15. female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery 16. patients who may require the use of hyaluronidase as part of the study cataract procedure 17. patients who may be regarded as being vulnerable (e.g. prisoners, residents of care or mental health institutions, trauma, war or disaster victims, dependent on the investigator etc.)
inspire singapore study

Conditions: Obstructive Sleep Apnea; OSA; Sleep Apnea

Summary: prospective, multicenter, open-label study designed to confirm device performance of inspire system in singapore.

patients who meet study eligibility criteria will be implanted with an inspire system and followed for 6 months post-therapy-activation. study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st psg, after therapy activation), titrate the therapy (2nd psg, at 3 months post-activation) and confirm therapy performance (3rd psg, at 6 months post-activation). symptoms and quality of life (assessed by ess and fosq), therapy adherence, and adverse events will also be collected and reported.

Eligibility criteria:
main inclusion criteria: * diagnosis of moderate to severe osa (ahi 15-65) * failure of, or intolerance to cpap main exclusion criteria: * central + mixed apneas \> 25% of total ahi * presence of complete concentric collapse (ccc) * compromised neurological control of the upper airway. other eligibility criteria may apply.
immunogenic cell death as a novel mechanism of mitomycin c activity in bladder cancer

Conditions: Bladder Cancer

Summary: the principal objective of this study consists in the assessment of immunogenic cell death (icd) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with mitomycin c (mmc). the evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient

urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive bladder cancer (nmibc). nmibc management consist in transurethral resection of bladder tumor (turbt) followed by adjuvant intravesical treatment with the chemotherapeutic agent mitomycin c (mmc) or the immunotherapy bacillus calmette-guérin. these therapies result in low progression rates, but are not efficacious in all patients, leading to high tumor recurrence. immunogenic cell death (icd) may be one of the mechanisms of action of mmc intravesical therapy in bladder cancer. the primary objective of the study is to evaluate whether mmc is able to trigger icd in patient-derived neoplastic tissues. as secondary targets we aim to: 1. identify an expression profile that is common to all tumors that undergo icd upon mmc treatment ('icd signature'), 2. asses the genetic and environmental factors- urinary microbiome composition- responsible for mmc treatment efficacy, 3. evaluate whether icd induction correlates with clinical staging and response (clinical endpoints for mmc-treated patients are recurrence at three month and one year after enrollment).

Eligibility criteria:
inclusion criteria: - male and females, \> 40 years old for bladder cancer patients: - bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy exclusion criteria: * treated with immunomodulatory agents at time of enrollment or in the two months before enrollment * treated with antibiotics at time of enrollment or during the month before enrollment * positive history of sexually transmitted diseases * urinary infection ongoing or recent (during the three months before enrollment) * suffering from chronic intestinal inflammation only for controls: * treated with immunomodulatory agents at time of enrollment or in the two months before enrollment * treated with antibiotics at time of enrollment or during the month before enrollment * positive history of sexually transmitted diseases * urinary infection ongoing or recent (during the three months before enrollment) * suffering from chronic intestinal inflammation
duration of antibiotic therapy in acute kidney graft pyelonephritis (agpn): effect on the risk of recurrence

Conditions: Pyelonephritis Acute; Kidney Transplantation Recipients

Summary: the aim of this study is to evaluate the impact of the duration of antibiotic therapy on the risk of recurrence in kidney graft pyelonephritis. the secondary objectives are to identify the factors associated with the duration of antibiotic therapy in acute kidney graft pyelonephritis, identify the factors associated with recurrence of acute kidney graft pyelonephritis within 3 months, evaluate the impact of the duration of antibiotic therapy on antibiotic-related complications and assess the impact of the duration of antibiotic therapy on the progression of renal function after acute kidney graft pyelonephritis.


Eligibility criteria:
inclusion criteria: * adult patients * kidney transplant recipients with a functional graft. * hospitalization with acute pyelonephritis (apn) defined by fever or chills (noted in the clinical records) and bacteriuria and exclusion of another obvious cause of fever. (for rehospitalizations, also include cases where antibiotic therapy was initiated based on suspicion, even in the absence of documented infection.) exclusion criteria: * age \< 18 years. * vacationing patient or lost to follow-up with follow-up \< 3 months.

Keywords: acute graft pyelonephritis duration treatment antibiotic recurrence relapse
the national center for testing treatments in chronic spinal cord and traumatic brain injury

Conditions: Spinal Cord Injury; Traumatic Brain Injury

Summary: the nctt is a prospective, multicenter, observational research network for subjects with chronic spinal cord and/or chronic traumatic brain injury.

current treatment for spinal cord injury and traumatic brain injury focuses on stabilizing the patient and preventing secondary injury with the aim of maximizing the best chance of recovery. most patients will show varying amounts of recovery, but, when the injury is severe, that recovery is only partial. enrollment in the nctt will allow for classification and characterization of injury, function, co-morbidities, secondary issues/problems, research interests and will serve as a conduit for enrollment into interventional studies.

Eligibility criteria:
inclusion criteria: * history of spinal cord injury and/or brain injury * able to provide hipaa authorization to share prior medical records/imaging * age 18 and older. exclusion criteria: * life expectancy less than 6 months, vegetative state or co-existing disease or other characteristic that precludes appropriate diagnosis of spinal cord or brain injury. * other condition that, in the opinion of the site investigator, would interfere with adherence to study requirements. * inability or unwillingness of subject or legal guardian/representative to give informed consent (e.g., ward of the state).

Keywords: spinal cord injury traumatic brain injury
comparison study of cefazolin versus cefazolin plus azithromycin prophylaxis in post-cesarean endometritis

Conditions: Endometritis

Summary: despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as the most frequent post-cesarean delivery complication. this increased morbidity translates into extended post-partum antibiotic use and prolongation of hospital stay with the subsequent increase in health care expenses. the current regimen recommended by the american college of obstetricians and gynecologists for cesarean delivery prophylaxis (1st generation cephalosporins) does not cover for ureaplasma urealyticum, a microorganism that has been associated with an increased risk of endometritis in post-cesarean section patients. azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely covers ureaplasma and would be an excellent second antibiotic for cesarean section chemoprophylaxis. our hypothesis is that the addition of azithromycin to standard chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section endometritis.


Eligibility criteria:
inclusion criteria: * pregnant patients between 37 and 42 weeks gestational weeks. * pregnant patients undergoing indicated cesarean section at truman medical center hospital july 2012 and july 2014. * pregnant patient that received prenatal care at truman medical center. hospital hill, samuel rogers or swope parkway health centers at least 1 month prior to the cesarean delivery. * signed informed consent. exclusion criteria: * allergy to cephalosporins or azithromycin. * refusal to sign consent form. * clinical signs of chorioamnionitis: fever 100.4 f or higher, uterine tenderness, maternal or fetal tachycardia. * immunocompromised condition: hiv positive with cd4 count below 200, chronic steroid use, pregestational diabetes, cancer, chemotherapy. * need for emergent cesarean precluding consent or availability of study medication. * need for hysterectomy at cesarean section. * use of antibiotic in the 72 hours prior to admission.
effects of interleukin (il)-17a inhibition on idiopathic subglottic stenosis

Conditions: Idiopathic Subglottic Stenosis

Summary: the purpose of this phase 2 study is to examine if inhibiting il-17a activation using the biologic drug taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries.

the purpose of this phase 2 study is to examine if inhibiting il-17a activation using the biologic drug taltz, in idiopathic subglottic stenosis patients will decrease scar fibroblast proliferation therefore reducing or eliminating the need for invasive or repeat surgeries. inhibition of the il-17a pathway can slow or reverse the inflammation causing airway narrowing in patients with idiopathic subglottic stenosis. this would have a significant impact on quality of life for patients living with this diagnosis as it may help them to avoid frequent surgical procedures, recoveries and associated costs. this is a single arm, open-label study where all participants will receive drug. the study population is patients with a documented diagnosis of idiopathic subglottic stenosis who are followed at yale new haven hospital.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * diagnosis of idiopathic subglottic stenosis exclusion criteria: * history of active or latent tuberculosis infection * history of inflammatory bowel disease * pregnancy or lactation * known allergic reactions to study drug * disease involving the vocal cords * individuals who are taking drugs known to trigger angioedema, including use acquired angioedema from drugs such as ace inhibitors (e.g. lisinopril) and nonsteroidal anti-inflammatory drugs (nsaids) and individuals with a history of other forms of angioedema such as hereditary and clesterase deficiency

Keywords: il-17a inhibition
clinical outcomes between tibial preservation bone cut and conventional tibial bone cut following medial uka

Conditions: Knee Osteoarthritis; Knee Arthropathy

Summary: the mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. however, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. the medial knee pain after operation was the one cause of revision. the incidence of medial knee pain was 0%-9%. the cause of medial knee pain was overloading on the medial plateau, local inflammation, over hanging of the tibial component and overstretching of the mcl due to the application of excessive polyethylene. therefore, the tibia in this study was cut with under resection technique for reducing the overloading on the medial tibial plateau. the purpose of this study is to compare medial knee pain between tibial bone cut preservation technique and conventional tibial bone cut technique following mobile bearing uka.

a randomized control trial study was conducted at thammasat university hospital, thailand. the inclusion criteria were patients with medial osteoarthritis (oa) of the knee with an alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement (rom) \> 90°, a varus deformity \< 25°, and flexion contracture \< 20° who underwent a medial mobile bearing uka (oxford uka; zimmer biomet, inc, warsaw, in, usa), performed by a single surgeon. the exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (sponk), intraoperative anterior cruciate ligament (acl) insufficiency, inflammatory joint disease, gout, post-traumatic arthritis, and primary pf arthritis. the patients were randomized with computer technique into 2 groups, group (gp) i, conventional tibial bone cut technique and gp ii, tibial bone cut preservation technique. the baseline patient characteristics included age, sex, site, the knee society score© (kss) (knee score, pain score, and functional score), oxford knee score (oks), koos, kujara score, body mass index (bmi), degree of varus deformity, flexion contracture, genu recurvatum, and range of motion (rom) were recorded. the patients were followed up at 2 weeks, 6 weeks, 3months, 6months, 1 years, and annually. the vas ofr medial knee and incidence of medial knee pain were assessed in a blinded fashion by a research assistant at each visit using vas scale (0-10). the kss, oks, koos, and kujara score also were recorded. at each follow-up, the patients underwent ap standing, lateral standing, skyline view, and long-leg radiographs and the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.

Eligibility criteria:
inclusion criteria: * medial osteoarthritis of knee exclusion criteria: * posttraumatic arthritis * gout * rheumatoid arthritis * anterior cruciate ligament insufficiency * osteonecrosis of knee

Keywords: mobile bearing uka oxford uka medial knee pain
fasting for brain and heart health (fbhh)

Conditions: Insulin Resistance

Summary: this pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (homa-ir), a measure of insulin resistance.

ischemic stroke is a leading cause of death and a major public health burden. data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. nonetheless, current intervention strategies have done little to reduce overall stroke incidence. therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke. this pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (homa-ir), a measure of insulin resistance. additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.

Eligibility criteria:
inclusion criteria: * any gender * 40-70 years old * fasting plasma glucose \<12 6mg/dl and/or hemoglobin a1c \<7% * body mass index (bmi) \>25 kg/m2 * elect and qualify for a water-only fast of at least 10 consecutive days * provide informed consent exclusion criteria: * active malignancy * active inflammatory disorder including classic autoimmune connective tissue (lupus, sjogrens, anca), multiple sclerosis, and inflammatory bowel disorders (ulcerative colitis, crohn's) * stroke or heart attack within the last 90 days
neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in estrogen receptor (er)-positive, her2-positive breast cancer

Conditions: Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer

Summary: neopehp is a multicohort, open-label, exploratory, phase 2 study. patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, her2-positive, er-positive breast cancer and were suitable for neoadjuvant therapy. patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po qd) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po qd) every 4 weeks for 24 weeks. the primary endpoints was pathological complete response.


Eligibility criteria:
inclusion criteria: * we judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, her2-positive (3+ on immunohistochemistry or neu-amplified) and er-positive (\>10% of cells in the tumour expressing er) breast cancer. other inclusion criteria were age 18 years or older, eastern cooperative oncology group (ecog) performance status of 1 or less, and tumour classified between ct1c and ct4a-d. exclusion criteria: * metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.